Information for sponsors of clinical trials/submitters of Development Safety Update Reports (DSURs)

Sponsors shall submit the DSUR for the investigational medicinal product on an annual basis. The DSUR shall reflect any newly available information obtained in the course of the period to which the report pertains. The report shall contain information as referred to under ICH guideline E2F, Note for guidance on development safety update reports, September 2010.  

The DSUR shall be submitted to SÚKL for clinical trials (CT) active in the Czech Republic for the period from the date of approval of the clinical trial by SÚKL until its completion (note: the CT completion is defined by the CT protocol). A DSUR covering this entire period must be submitted to SÚKL.

DSURs shall be sent solely electronically, in the pdf format to DS or by e-mail: posta@sukl_cz (this method of report submission is preferred) or by post on media (CD) together with a cover letter which should specify the identification of all CTs (EudraCT number and/or SÚKL´s file number, and, if appropriate, the protocol ID), to which the DSUR pertains, and contact details of the authorised person in case comments or further questions arise.

 

Department of Clinical Trials on Pharmaceuticals

Date 22nd January 2018